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European Pharmaceutical Contractor

Editors Letter

“The pharmaceutical industry is in crisis.” We have been hearing this message for at least 20 years. However, the industry continues to exist and, to quite a large extent, is resistant to change.

This quarter’s EPC sees Heather Fraser at IBM discuss why she feels the life sciences industry stands at a crossroads – should it continue with its existing, conservative approach, or totally rethink how it operates in the wider healthcare world. She lays out some of the reasons why she believes the industry is in crisis, highlighting the changes to global healthcare as one of the major challenges that it must contend with. She argues that leaders in the industry no longer expect to manage their way through this rapidly changing environment, but rather believe that success will depend upon their ability to innovate through it.

Innovation in R&D is a topic that is addressed by Matt Kingdon and Jon Platt at ?What If!. They also see that pharmaceutical R&D is facing urgent issues. One of the inhibiting factors in developing new medicines, in their view, is the institutional conservatism of R&D departments. They believe that the most important driver of innovation is passion. Three approaches are outlined which they feel may develop passion in R&D teams. The first of these involves actually meeting with consumers. The second is to try to abolish the closed mind of certain R&D personnel and to think extensively rather than reductively. In the third approach, they identify the ability to foresee how bets placed will pay off in 10-20 years’ time.

The first of these approaches would, I believe, strike a chord with Lisa Chamberlain James at Trilogy, who discusses the provision of consumer information by the industry and how today’s patients can obtain information from a wide variety of other sources, notably the internet. Lisa states that doctors have become exasperated with patients who have not only followed this advice, but have brought with them recommendations for their own treatment, based on self-diagnosis.

Herein lies one of the challenges of the industry: not only are an alarming percentage of the public functionally illiterate, but also the vast majority of patients are scientifically and medically untrained and are incapable, through no fault of their own, of interpreting the conflicting information they receive from their medical practitioner or medically-based websites. Lisa proclaims that the industry needs to focus on making sure that patient information summaries communicate in a way that the general public understands. The danger to the industry and the regulators is that ‘dumbing down’ patient information may make it inaccurate or open to misinterpretation.

Continuing the theme of regulators, Markus Hartmann of ECC Oncology produces an appraisal for us of the latest proposals affecting the European Commission’s Clinical Trials Directive. He believes that the proposal to revise the existing Directive, which the Commission itself conceded “was arguably the most heavily criticised piece of European Union legislation in the area of pharmaceuticals,” is very promising. The Commission has understood messages from stakeholders and now places a stronger reliance on public health benefits, an increasing focus on the robustness of data, reliance on improved trial design and improved monitoring, which will influence long-term outcomes from this revision. Markus warns, however, that the final proposal is not a done deal and that discussions, not to say negotiations, between member states, national agencies and Parliamentarians will need to take place before the final document is in place.

Other articles in this issue address topics such as Russia and China, imaging, and early disease and adverse event monitoring; they make this first issue of 2013 as lively and stimulating as ever!

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